Significant myelofibrosis (>+fibrosis)
No documented myelofibrosis at screening marrow biopsy
Patients with history of primary idiopathic myelofibrosis or any severe marrow fibrosis.
Advanced myelofibrosis
Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.
Confirmed diagnosis of primary myelofibrosis or post-polycythemia vera / essential thrombocythemia myelofibrosis classified as high risk, intermediate- risk, or intermediate risk by International Prognostic Scoring System (IPSS)
Participant has history of myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL translocation and AML with BCR-ABL translocation.
Participant had an antecedent myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia (CML) with or without BCR-ABL translocation and AML with BCR-ABL translocation.
Must have a diagnosis of chronic phase (CP) (defined as peripheral blood and bone marrow < % blasts) primary myelofibrosis (PMF) or post essential thrombocythemia (post-ET) or polycythemia vera (post-PV) myelofibrosis by World Health Organization (WHO) criteria OR a diagnosis of a myeloproliferative neoplasm in accelerated/blast phase (MPN-AP/BP) defined as either a peripheral blood or bone marrow with >= % blasts
Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis
Myeloproliferative neoplasms/myelofibrosis
Diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera (post-PV) myelofibrosis (MF) or post-essential thrombocythemia (post-ET) MF based on the World Health Organization (WHO) criteria or the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria, which must be confirmed by bone marrow (BM) aspirate and/or biopsy within weeks prior to screening; measurement of janus kinase (JAK) VF allele burden in BM samples, if not done within months prior to screening, must be provided with the screening BM biopsy/aspirate report (patients are eligible regardless of JAK mutation status)
Myeloproliferative neoplasms/myelofibrosis
Confirmed diagnosis of myelofibrosis (primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia vera) by World Health Organization (WHO) diagnostic criteria ( major and minor criteria: major criteria: megakaryocyte proliferation and atypia with either reticulin and/or collagen fibrosis, not meeting criteria for chronic myelogenous leukemia [CML], polycythemia vera [PV], myelodysplastic syndrome [MDS], or other myeloid neoplasm, JAKVF or other clonal marker or no evidence of reactive marrow fibrosis; minor criteria: leukoerythroblastosis, increased lactate dehydrogenase [LDH], anemia, palpable splenomegaly)
No prior treatment for myelofibrosis (for cohort only)
Myeloproliferative neoplasms (MPN) and myelodysplastic/myeloproliferative overlap neoplasms\r\n* Myelofibrosis with adverse-risk features\r\n* Polycythemia vera\r\n* Essential thrombocythemia\r\n* Chronic myelomonocytic leukemia
Patients with a diagnosis of primary myelofibrosis (PM), post polycythemia vera myelofibrosis (PPV MF), or post essential thrombocythemia myelofibrosis (PET MF) requiring therapy, including those previously treated and relapsed or refractory, or if newly diagnosed, with intermediate or high risk according to International Working Group (IWG-MRT) criteria
Must not have myelofibrosis or other disease known to prolong neutrophil engraftment to > days after transplant
MPN-associated myelofibrosis
Use of any MPN-associated myelofibrosis-directed therapy within weeks prior to study day
Patients with primary idiopathic myelofibrosis
Advanced myelofibrosis
Myeloproliferative neoplasms/myelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to Dynamic International Prognostic Scoring System (DIPSS) criteria; blasts must be < % by bone marrow aspirate morphology
Chronic myeloproliferative disorder, i.e. myelofibrosis
Myeloproliferative disorders\r\n* Idiopathic myelofibrosis\r\n* Polycythemia vera\r\n* Essential thrombocytosis\r\n* Chronic myelomonocytic leukemia\r\n* Patients with myeloproliferative disorders must be end-stage, which is primarily defined as disease severity refractory to splenectomy
Patients should not meet criteria for post PV or post ET-myelofibrosis (MF)
Documented diagnosis of primary myelofibrosis according to World Health Organization (WHO) criteria or post polycythemia vera (PV) myelofibrosis or post essential thrombocythemia (ET) myelofibrosis as per IWG-MRT criteria
Patients should not meet criteria for post PV or post ET-myelofibrosis (MF)
Accelerated phase myeloproliferative neoplasm (MPN) as defined by %-% blasts in the peripheral blood or bone marrow and evidence of dysplastic marrow features with a concomitant diagnosis of essential thrombocythemia (ET), polycythemia vera (PV) or primary myelofibrosis (PMF) or a diagnosis of acute myelogenous leukemia as defined by % blasts in the blood or bone marrow following a previous diagnosis of ET, PV or PMF
Patients with acute myelofibrosis are excluded
Participants with documented diagnosis of primary Myelofibrosis, post polycythemia Vera Myelofibrosis or post-essential thrombocythemia myelofibrosis
MPD: Patients with essential thrombocythemia with persistent thrombotic or hemorrhagic complications despite conventional therapy, or who have progressed to myelofibrosis
MPD: Chronic idiopathic myelofibrosis with peripheral blood cytopenias
At least four weeks must have elapsed between the last dose of any MF- directed drug treatments for myelofibrosis (including investigational therapies) and study enrollment;
Requires myelofibrosis therapy, in the opinion of the investigator
Diagnosis of myelofibrosis (either primary or post essential thrombocythemia/polycythemia vera) requiring therapy, including those previously treated and relapsed or refractory, or if newly diagnosed, with intermediate- or - or high risk according to International Working Group (IWG) criteria
History of primary idiopathic myelofibrosis
Patients must have a histologically confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera (post-PV) myelofibrosis (MF), or post-essential thrombocythemia (post-ET) MF using World Health Organization Criteria
Meets the criteria for post ET/PV myelofibrosis (MF) as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
Subject has a history of myeloproliferative neoplasm (MPN) including polycythemia vera, myelofibrosis, essential thrombocythemia, or chronic myelogenous leukemia.
If receiving myelofibrosis therapy, must be on a stable dose of the same regimen for at least weeks prior to screen date and through the screening period
post-polycythemia vera/essential thrombocythemia myelofibrosis (Post-ET/PV MF) per the International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria
Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
Intermediate- and higher by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) post polycythemia vera (PV)/essential thrombocythemia (ET) MF and primary myelofibrosis (PMF) patients either in\r\n* Chronic phase (MF-chronic phase [CP])\r\n* Accelerated phase (MF-accelerated phase [AP])
Primary myelofibrosis, post-PV MF, or post-ET MF that requires therapy
No MF-directed treatment for at least weeks prior to initiation of NS-, including any use of corticosteroids for Myelofibrosis symptom or blood count management. Low dose corticosteroids ? mg/day prednisone or equivalent is allowed for non-myelofibrosis purposes.
Myeloproliferative disorders (idiopathic myelofibrosis, polycythemia vera, essential thrombocytosis, chronic myelomonocytic leukemia, agnogenic myeloid metaplasia)\r\n* Agnogenic myeloid metaplasia with adverse-risk features \r\n* Polycythemia vera or essential thrombocythemia in transformation to secondary AML
Patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis
History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.
Patients with idiopathic myelofibrosis or myelofibrosis secondary to polycythemia vera or essential thrombocythemia
Patients with low risk myelofibrosis
Intermediate - or - or high-risk Myelofibrosis (per Passamonti et al )
At least - weeks since prior myelofibrosis therapy, including any erythropoietic or thrombopoietic agent
Requires myelofibrosis therapy, in the opinion of the investigator
Histologically documented diagnosis of myelofibrosis (MF) (idiopathic or post polycythemia vera [PV]/essential thrombocythemia [ET])
Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
Part II: Patients with one of the following documented conditions: CML in CP that is Philadelphia chromosome (Ph)-positive (by cytogenetics) or BCR-ABL-positive by fluorescent in situ hybridization [FISH], or PCR), as well as resistant to at least FDA-approved tyrosine kinase inhibitors (TKIs); or a myeloproliferative neoplasia which includes: PMF and myelofibrosis secondary to polycythemia vera (PV) and essential thrombocythemia (ET) myelofibrosis (MF) (with intermediate-, intermediate- or high risk disease according to the International Working Group [IWG] prognostic scoring system) (i.e., Non-Acute Group patients).
Patients must have a histologically confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera (post-PV) myelofibrosis (MF), or post-essential thrombocythemia (post-ET) MF using World Health Organization Criteria
Philadelphia chromosome negative myeloproliferative disease (including myelofibrosis)\r\n* Intermediate- or high risk score by Dynamic International Prognostic Scoring System (DIPSS) Plus is required for a diagnosis of myelofibrosis
Patients with history of primary idiopathic myelofibrosis or any severe marrow fibrosis
Patients with aplastic anemia or primary myelofibrosis; patients with marrow fibrosis secondary to myelodysplastic syndrome (MDS), AML or a myeloproliferative disorder other than primary myelofibrosis are eligible
Subjects with a history of primary idiopathic myelofibrosis.
Subject has a confirmed diagnosis of myelofibrosis, including PMF, post-PV MF, and post-ET MF.
Primary or secondary myelofibrosis
Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis per World Health Organization criteria